Pilot Study on the Use of Acupuncture for Postpartum Depression

Post-partum Depression Clinical Trial

Official title:

Pilot Study on the Use of Acupuncture for Postpartum Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01178008
• Other study ID #: Acup-003
• Status: Completed
• Phase: N/A
• First received: August 1, 2010
• Last updated: January 14, 2013
• Start date: May 2010
• Est. completion date: June 2012

Study information

• Verified date: January 2013
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

The proposed study is a randomized controlled trial to examine the efficacy and safety of active acupuncture versus placebo acupuncture for the treatment of postpartum depression. The investigators hypothesis is that active acupuncture would be superior to placebo acupuncture in the short-term treatment of postpartum depression.

Description:

This study will be a randomized, controlled, subject- and assessor-blind trial in patients with postpartum depression. Eligible subjects will be randomly assigned to active acupuncture or placebo acupuncture. The subjects will receive acupuncture treatment twice per week for 4 consecutive weeks. The acupuncturist of this trial will not participate in data collection and data entry. The trial assessor will be blind to the subjects' treatment allocation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ethnic Hong Kong Chinese aged 18 years or above;

• Within 6 months of giving birth;

• Edinburgh Postnatal Depression Scale (EPDS) (Cox et al., 1987) score higher than or equal to 12 or being diagnosed as depressed by their obstetrician;

• Meeting the Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis criteria for major depressive disorder;

• 17-item Hamilton Depression Rating Scale (HDRS17) (Hamilton, 1960) score of between 12 and 19 at screening and baseline assessment;

• Willingness to give informed consent and comply with trial protocol.

Exclusion Criteria:

• Suffering from other psychiatric disorders such as schizophrenia, other psychotic disorders, bipolar disorder or substance use disorder;

• Serious physical illnesses or mental disorders due to a general medical condition which are judged by the investigator to render unsafe;

• A significant risk of suicide according to the rating of HDRS17 item 3 (score higher than 2), i.e., presence of ideas or gesture of suicide;

• A presence of idea of self-harming according to the rating of EPDS item 10 (score higher than 0);

• A significant risk of infanticide according to the investigator assessment;

• Any acupuncture treatment during the previous 12 months prior to baseline;

• Valvular heart defects, bleeding disorders or taking anticoagulant drugs;

• Infection or abscess close to the site of selected acupoints;

• Herbal remedies or psychotropic drugs that are intended for depression are taken within the last 2 weeks prior to baseline or during the study.

• Receiving counseling or psychological therapies at baseline or during the study;

• Participation in any clinical trial within the previous 3 months prior to baseline;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Post-partum Depression

Intervention

Procedure:
• Active acupuncture
Active acupuncture regimen consists of electroacupuncture stimulation on cranial and body acupoints which are empirical for treating depression in term of traditional Chinese medicine theory. It is done by a registered Chinese medicine practitioner with at least 3 years experience of providing acupuncture treatment. An electric-stimulator is connected to these needles to give an electric-stimulation in a continuous wave The needles will be left for 30 min and then removed. Acupuncture treatment will consist of two sessions per week for 4 consecutive weeks.
• Placebo acupuncture
Streitberger's non-invasive acupuncture needles will be applied to serve as placebo control at the same acupoints and the same stimulation modality, except that the needles only affixed on the skin with adhesive tapes instead of insertion. Since all the points used are beyond patients' vision as they lay on bed, they could not visualize the acupuncture procedure. The acupuncturist, setting, treatment frequency, and duration of the treatment course are the same as the active acupuncture group.

Locations

Country	Name	City	State
Hong Kong	Kwong Wah Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Tsan Yuk Hospital	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
The University of Hong Kong	Hospital Authority, Hong Kong, Kwong Wah Hospital

Country where clinical trial is conducted

Hong Kong, 

References & Publications (2)

Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. — View Citation

HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23:56-62. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	17-item Hamilton Depression Rating Scale	To assess Depressive symptoms	8 weeks	Yes
Secondary	Hospital Anxiety and Depression Scale (HADS)	To assess depression and anxiety	8 weeks	No
Secondary	Sheehan Disability Scale	To assess subjects' functioning in work/study, social life and family	8 weeks	No
Secondary	Clinical Global Impression Scale	To assess severity of illness and improvement due to treatment	8 weeks	No
Secondary	Edinburgh Postnatal Depression Scale	To assess subjective Depressive symptoms	8 weeks	Yes